MAPS-Bulletin-Summer-2010-MAPS-Research-Update, medyczne- książki j ang
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MULTIDISCIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES
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maps bulletin • volume xx number 2
VOLUME XX NUMBER 2
From the desk of Rick Doblin, Ph.D.
O
ne barometer
of success for social
change movements is whether their strug-
gles, spanning decades or longer, are taken
for granted by new generations. I saw hints of this July 29
when I spoke about MAPS’ research into MDMA-assisted
psychotherapy for posttraumatic stress disorder (PTSD)
to about 50 psychiatrists, psychotherapists and other
medical professionals in the Department of Psychiatry at
Kaiser Permanente Hospital in San Francisco. To my sur-
prise and satisfaction, the healing professionals were not
that interested in my chronicle of our quarter-century of
struggles between the DEA’s criminalization of MDMA
on July 1, 1985, which outlawed all uses, and the July
19, 2010, Journal of Psychopharmacology publication of
the results of MAPS’ U.S. MDMA/PTSD pilot study. The
Kaiser staff were far more interested in practical details
regarding our safety and eficacy data from the world’s
irst completed, controlled study of the therapeutic use of
MDMA.
I knew we’d entered a new era when I was asked about
the casualties of a recent Bay area rave that resulted in
an Ecstasy-related death and lasting damage to a young
woman who was treated at this very same hospital.
Within a few minutes, I was able to acknowledge and
differentiate the risks of Ecstasy taken in uncontrolled
settings with the risks of pure MDMA administered to
screened subjects in therapeutic research. For decades,
fears about the risks of the non-medical use of Ecstasy
were suficient to derail research and interest in the
medical uses of MDMA. My experience at Kaiser demon-
strated to me how far we have progressed in our mission
to mainstream psychedelic psychotherapy.
Meanwhile, our new MDMA-assisted psychotherapy
study with veterans suffering from war-related PTSD
is fully approved and about to begin, while signs of our
growing mainstream acceptance can be found in the
more than 140 media articles about our paper.
• On July 19, Roger Pitman, M.D., PTSD expert and Pro-
fessor of Psychiatry at Harvard Medical School and Mas-
sachusetts General Hospital, was quoted in an article in
The Boston Globe. He called our research “promising,”
and the results impressive and deserving of further
investigation.
• In a July 20 WebMD article, Charles R. Marmar, M.D.,
Chair of Psychiatry at New York University’s Langone
Medical Center, referenced our work as a “well-con-
ducted clinical trial showing positive effects. MDMA
appears to be reasonably safe and effective and requires
more trials. …The fact of the matter is that these are
dificult-to-treat patients, so having another tool in the
armamentarium would be helpful. Assuming it is done
under highly professional conditions and patients didn’t
have history of abuse, there is no reason to believe it
would be dangerous – yet we need more work to ind
out what the risks are.” Marmar’s comments are espe-
cially relevant because he represented Pizer, manufac-
turer of Zoloft, in the FDA’s 1999 Advisory Committee
hearing that resulted in the approval of Zoloft for the
treatment of PTSD.
• Also in WebMD, Harriet deWit, Ph.D., Professor of Psy-
chiatry and Behavioral Neuroscience at the University
of Chicago and a NIDA-funded neuroscientist who has
seen the MDMA neurotoxicity debate from the begin-
ning, remarked, “The results were quite dramatic and it
is proof of concept and very good early evidence.”
• In the Aug. 4 edition of the Toronto Sun, Lt. Col. Rakesh
Jetly, a psychiatrist and senior health adviser for the
Canadian Armed Forces, said about our research, “We’re
in the business of stopping suffering and if something is
shown to do it, then we would certainly give it serious
consideration.”
With these experts calling for more research, our
momentum is building. MAPS’ so far fruitless efforts to
collaborate on MDMA/PTSD research with the U.S. De-
partment of Veterans Affairs, the Department of Defense
and the National Institute on Mental Health no longer
seem so far-fetched.
The incredible progress we have made in the past few
years allows us to move beyond the politics of MDMA
and expand our research into the healing potential of
psychedelics. While unfortunately our medical marijuana
research efforts are still blocked by politics over science,
even that will change eventually. With your continued
support for our expanding research agenda, we look for-
ward to being taken for granted.
Rick Doblin, Ph.D., MAPS Executive Director,
rdoblin@maps.org
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maps bulletin • volume xx number 2
mdma research
Mithoefer Receives DEA License for Phase 1
Psychological Effects/Therapist Training
Study; License for U.S. MDMA/PTSD Veterans
Study Coming Soon
On August 9, Michael Mithoefer, M.D., received a Schedule I
license from the Drug Enforcement Administration (DEA)
to administer MDMA in our Phase 1 study to investigate the
effects of MDMA on healthy volunteers (limited to thera-
pists enrolled in our therapist-training program). He waited
approximately seven months to receive the license. This is a
relatively short period compared with 19 months last time he
was licensed. The DEA also told Dr. Mithoefer to expect his
license for our Veterans study soon, which would be only 4
months from the time of application. The FDA and Institutional
Review Board (IRB) approved both of these studies months
ago, so we’ve just been waiting on the DEA’s Ofice of Drug and
Chemical Evaluation (ODE) to issue the licenses. The studies
are co-lead by Ann Mithoefer, B.S.N.
Psychological effects on Healthy Volunteers/therapist-
training Study
On October 3, 2009, the FDA approved our protocol for
studying the effects of MDMA on healthy volunteers. On
December 21, 2009, the protocol was approved by the IRB. In
this study the Mithoefers will administer MDMA to healthy
volunteers who are part of our therapist-training program. The
goal of this study is two-fold: (1) the study will allow us to
learn more about the psychological effects of MDMA-assisted
psychotherapy in healthy individuals; and (2) the therapists in
our training program will have the opportunity to have a irst-
hand experience with MDMA, which we suspect will enable
them to be better therapists in our future studies.
We are anticipating we will need 20–30 therapist teams in
approximately three years for our two large-scale, multi-site,
Phase 3 studies. Since the training program can take a long
time, we are currently soliciting more applications from quali-
ied therapists interested in conducting clinical research with
MAPS. Applications are encouraged from therapists with some
or all of the following qualiications: 1) treated patients with
PTSD, 2) worked with non-ordinary states of consciousness,
and/or 3) conducted clinical research. Applications from male/
female teams are highly encouraged. If interested, please con-
tact Berra Yazar-Klosinski, Ph.D. at: berra@maps.org
Veterans Study
We are in the process of recruiting subjects for our MDMA-
assisted psychotherapy study for veterans with war-related
PTSD. We are recruiting subjects primarily from Charleston,
SC, to save approximately $5,600 in travel expenses for each
out-of-town subject. We are mostly seeking veterans from the
Iraq and Afghanistan wars, but subjects with PTSD from the
Vietnam War are eligible. We are trying to recruit equal num-
bers of men and women.
The study will be our second MDMA/PTSD study to take
place in Charleston, SC. Subjects in the Mithoefers’ previous
study primarily had PTSD brought on by sexual assault, abuse
and violent crime, with just two veterans with war-related
PTSD. This new study will only enroll veterans, so that we can
evaluate if the treatment for war-related PTSD is the same or
different than the treatment for the aforementioned causes.
We will also be able to enroll subjects with the previously
excluded risk factors of Hepatitis C and controlled hyperten-
sion, with additional screening evaluations and safety measures
for these subjects.
news updates
Journal of Psychopharmacology Publishes
Paper about MAPS’ U.S. MDMA/PTSD
Pilot Study
On July 19, 2010, the Journal of Psychopharmacology
published a paper about the MAPS-sponsored U.S. MDMA/
PTSD pilot study. The paper is titled “The safety and eficacy of
3,4-methylenedioxymethamphetamine-assisted psychotherapy
in subjects with chronic, treatment-resistant posttraumatic
stress disorder: the irst randomized controlled pilot study,” and
is authored by Michael Mithoefer, M.D., Mark Wagner, Ph.D.,
Ann Mithoefer, B.S.N., Lisa Jerome, Ph.D., and Rick Doblin,
Ph.D. This is cause for major celebration since this is the irst
paper ever published about a completed study of MDMA-assist-
ed psychotherapy for posttraumatic stress disorder (PTSD).
Our drug development efforts do not require our research
to be published in peer-reviewed scientiic journals, but this
greatly enhances our public education efforts. Since the pub-
lication was released, there have been more than 150 news
reports around the globe about the study, some as far away
as Pakistan and Australia. Many of these news reports were
in major media outlets such as Time.com, New Scientist, the
Boston Globe, and Fox News. Media reports also appeared in
signiicant medical resources such as Medscape, WebMD, and
Nursing Times. Even Military.com, whose ten million members
make it the most active online news source for persons associ-
ated with the U.S. military, reported positively about the study.
This article will help us gain support for our upcoming study
in veterans with war-related PTSD. We have reposted many
of these reports on our website at: www.maps.org/media
The full text of the journal article can be found at: www.
maps.org/mdma/ptsdpaper.pdf
Long-term Follow-up of U.S.
MDMA/PTSD Pilot Study is Complete
On July 27, 2010, MAPS Deputy Director Valerie Mojeiko
and Clinical Research Associate Berra Yazar-Klosinski, Ph.D.
completed data collection for the long-term follow-up to our
lagship U.S. MDMA-assisted psychotherapy for PTSD study
led by Principal Investigator Michael Mithoefer, M.D. and Co-
Investigator Ann Mithoefer, B.S.N. in Charleston, SC. Indepen-
dent rater Mark Wagner, Ph.D., from the College of Medicine,
Department of Neurology, collected Clinician-Administered
PTSD Scale (CAPS) measurements from 17 of the 20 subjects
who received treatment. All 20 subjects illed out a question-
naire developed internally to assess long-term effects. The av-
erage length of time between the inal experimental treatment
session and the follow-up data collection was three and a half
years. Preliminary analysis of the results suggests the beneits
of the treatment were maintained. MAPS’ clinical research
volunteers are inputting data into a validated database at the
MAPS ofice in Santa Cruz, CA. After the data is analyzed,
Dr. Mithoefer, et al, will write a new paper for submission to
a scientiic journal around the end of 2010.
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maps bulletin • volume xx number 2
Canadian MDMA/PTSD Study
Gains Institutional Afiliation
On July 19, 2010, Health Canada informed principal inves-
tigator Ingrid Pacey, M.D. that they would accept a letter from
the director of the University of Victoria’s (UVic) Center for
Addiction Research of British Columbia (CARBC) as proof of
afiliation with UVic/CARBC. This was a major hurdle in get-
ting the Canadian MDMA/PTSD study started. In Switzerland
and the U.S., we have been able to conduct our research without
any outside institutional afiliation, but Health Canada required
afiliation with a Canadian institute before we could import
MDMA for the study. We had obtained approval for the actual
protocol from both Health Canada and a Canadian Institutional
Review Board (IRB) by March 2009, so this delay for institu-
tional afiliation has been especially prolonged and frustrating.
Fortunately, we were not deterred from continuing to strive for
full approval for what will become the irst psychedelic research
study to take place in Canada in almost 40 years.
On July 22, 2010, Tim Stockwell, Ph.D. the Director of CAR-
BC, sent a letter to Health Canada conirming CARBC’s support
and afiliation with Dr. Pacey. In the letter, Stockwell wrote,
“I have reviewed the paper about the results of the [MAPS-
sponsored] U.S. MDMA/PTSD study… As a result, I found the
results to be promising and think it is of signiicant scientiic
importance that a Canadian MDMA/PTSD study is conducted
to see if the results can be replicated with a new co-therapist
team in a new location.”
Jordanian MDMA/PTSD Research Team
Visited U.S. for Training
From April 7-12, 2010, our Jordanian MDMA/PTSD team,
led by Nasser Shuriquie, M.D., participated in a six-day thera-
pist-training program conducted by the Mithoefers in Charles-
ton, SC. The Jordanian team consisted of Tayseer Shawash,
Ph.D., Mona Abdulhamid Alnsour, Ph.D., and licensed social
worker Rodina Abubaker. The training included a review of
our treatment manual in order to learn how to conduct therapy
in accordance with our treatment method. A major portion of
the training was viewing videos from our irst U.S. MDMA/
PTSD study. Now that the team has participated in the non-
drug training, each team member has the option to experience
MDMA by participating in our Phase 1 study of the psychologi-
cal effects of MDMA administered in a therapeutic setting to
healthy volunteers.
On April 13, 2010, the Jordanian team traveled from
Charleston, SC, to San Jose, CA, to attend our conference,
Psychedelic Science in the 21st Century, and a post-conference
workshop led by Stan Grof, M.D.
MDMA/PTSD Study in Israel Paused; Prospect
of Revised Israeli Study Being Investigated
On March 26, 2010, we closed our Israeli MDMA/PTSD
study to new subjects in order to provide more training to the
therapeutic teams and to our independent rater, to improve our
data collection processes, and to make several improvements
to the protocol. There were no Serious Adverse Events (SAEs)
and all patients had been treated without evidence of harm. We
have conducted preliminary analysis of the data from the ive
subjects who were treated and found self-reports of healing, but
quantitative measures did not correspond. Rick will visit Israel
in October to discuss procedures for restarting the study with
Principal Investigator Moshe Kotler, M.D. Though recruitment
had been slow, an oficial at the Israeli Defense Forces indicated
a willingness to refer soldiers with war-related PTSD once we
restart the study. We have learned from the Israeli study that
we need to provide all of our therapist teams with enhanced
training about MDMA-assisted psychotherapy, protocol adher-
ence, and data collection, prior to a study’s initiation. We also
have learned that we need a single, dedicated research coordi-
nator for each site.
Switzerland MDMA/PTSD One-Year
Follow-Up Study Proceeds
On January 8, 2010, the last of the experimental treatments
were completed in the Swiss MDMA/PTSD study. The study,
led by Principal Investigator Peter Oehen, M.D., with Co-Inves-
tigator Verena Widmer, R.N., treated 12 subjects with chronic,
treatment-resistant PTSD. The investigators are currently
collecting data for the one-year, long-term follow-up phase of
the study. Eight subjects have already completed the long-term
follow-up, three subjects have not yet done so, and sadly, one
subject has died from an unrelated cause.
On June 14, 2010, at our ofice in Santa Cruz, CA, volunteer
clinical research intern Tim Whalen inished building and
validating the database for this study. On July 19, volunteer
research intern Audrey Redield, Ph.D. candidate (Institute of
Transpersonal Psychology) inished entering the preliminary
data into the database. Katharina Kirchner, M.A., who is as-
sisting our Swiss end-of-life anxiety study, will also assist the
investigators of this study with resolving data queries. The
inal analysis is scheduled for completion in January 2011, after
the last measurements are collected from the inal subject. We
anticipate that the results will be submitted for publication in
Spring 2011.
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maps bulletin • volume xx number 2
MAPS’ Autumn
Beneit Events
MAPS is hosting several events this fall with the goal of generating funding for our clinical research projects and operational
expenditures, and educating the public about our mission and the state of psychedelic psychotherapy research.
Twilight
New York City
Sept. 25, 2010
After the sun sets, at the Hori-
zons: Perspectives on Psychedelics
conference, doors will open nearby
at Sullivan Hall for Twilight, a beneit
party for MAPS. Twilight will be a very
special event, with a keynote address
by Rick. Several renowned electronic
musicians, live bands, and combination
acts will perform late into the night.
The event is open to the public, and
anyone is welcome to attend regardless
of registration status for the Horizons
conference.
Individuals wishing to support
MAPS on a more personal level are
invited to an intimate dinner before
Twilight with Rick and other MAPS staff
and colleagues. Space at the dinner
is limited; please consider purchasing
your ticket today to secure your seat at
the table. Dinner patrons will enjoy ex-
pedited entry into Twilight, and access
to a small, reserved area that includes
beverages and fresh fruit throughout
the night.
www.maps.org/twilight
NY
Colorado
Therapist Techniques for MDMA-
Assisted Psychotherapy Workshop
Boulder, Colorado
Nov. 7, 2010
Rick and Marcela Ot’alora G.L.P.C., (a co-therapist from our former MDMA-
assisted psychotherapy for PTSD clinical study in Spain) will lead this workshop.
Topics will revolve around therapist techniques utilized during MDMA-assisted
psychotherapy, and will explore issues discussed in MAPS’ MDMA/PTSD Treatment
Manual, lessons learned from MAPS MDMA/PTSD pilot study, and theoretical
applications of these techniques for use outside of MDMA-assisted psychotherapy.
MAPS’ MDMA/PTSD drug development program will also be discussed.
www.maps.org/colorado2010
An Evening with MAPS/SSDP
Boulder, Colorado
Nov. 7, 2010
MAPS’ mission includes educating the public honestly about the risks and
beneits of psychedelics and marijuana. Students for Sensible Drug Policy (SSDP)
mobilizes and empowers young people to participate in the political process, push-
ing for sensible policies to achieve a safer and more just future, while ighting back
against counterproductive Drug War policies. MAPS and SSDP share a mutual
interest in rational, scientiically based education with respect to marijuana, MDMA,
LSD, ibogaine, and other substances. Brought together by these shared values,
MAPS and SSDP will co-host this beneit event with addresses by Rick and SSDP
Executive Director Aaron Houston and Associate Director Jon Perri. Videos from
both organizations will be aired throughout the evening, with music and dancing
to follow late into the night. We recommend purchasing a ticket soon to guarantee
your entrance to this extraordinary evening.
www.maps.org/colorado2010
If you are a business owner or philanthropist
and are interested in sponsorship opportunities
for any of these events, please contact
Brian Wallace,
MAPS Director of Field Development
at: brian@maps.org
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maps bulletin • volume xx number 2
Bay
Area
Bay
Area
LA
Reception at 99 High Art Collective
Venice, CA
Dec. 10, 2010
At 6 PM at 99 High Art Collective (www.99collective.com ) in Venice, join
fellow MAPS members, new friends, and MAPS staff at a reception for Catalysts,
our Los Angeles mini-conference. 99 High Art Collective is a one-of-a-kind visionary
art gallery that organized a live mural painting at Psychedelic Science in the 21st
Century. This reception is open to everyone and admission is free.
Lakeside Beneit
Oakland, CA
Nov. 12, 2010
Enjoy a light dinner and drinks at the scenic Lake Chalet overlooking Lake
Merritt in Oakland, CA. This will be a unique opportunity to meet Rick and members
of MAPS’ clinical research team and to hear irsthand about our various research
projects. Plus there will be opportunities for attendees to go out on an intimate
gondola ride around Lake Merritt!
www.maps.org/oakland2010
Catalysts: The Impact of Psychedelics
on Culture, Cognition, & Creativity
Mini-conference
Los Angeles
Dec. 11, 2010
This mini-conference will feature presentations on psychedelic science and clini-
cal research, the impact of psychedelics on cognition and creativity, and presenta-
tions on psychedelic inluences in art and culture. This event will take place at The
Downtown Independent theatre in downtown Los Angeles. Presenters and topics will
be announced on the MAPS website soon.
www.maps.org/la2010
Party at The Sanctuary for the Arts
Oakland, CA
Nov. 12, 2010
After dinner at Lake Chalet, join MAPS for late night entertainment inside of a
renovated church space at Oakland’s Sanctuary for the Arts. We are partnering
with several friends from the Burning Man community and beyond to bring at-
tendees an outstanding night of music, artwork, performance and dance. Tickets are
limited for this special event, so we advise you to purchase one before they sell out.
www.maps.org/oakland2010
Critical Components on the Rooftop
Los Angeles
Dec. 11, 2010
After Catalysts, MAPS will host an intimate evening beneit on the rooftop of
The Downtown Independent. Attendees will enjoy a light dinner and drinks with Rick,
members of MAPS’ clinical research team, and other MAPS colleagues.
www.maps.org/la2010
These events will feature auctions of rare
psychedelic memorabilia, including laboratory
glassware from Sasha Shulgin’s lab
(Alexander “Sasha” Shulgin and his partner Ann
documented the creation and exploration of MDMA,
2C-B, and hundreds of other psychedelic compounds
in their books PIHKAL and TIHKAL), original visionary
and limited addition artworks, signed Albert Hofmann
collector’s items (Albert Hofmann, Ph.D., is the late
chemist who invented LSD in 1938), and
one-of-a-kind jewelry and custom clothing.
Flux: at Temple of Visions
Los Angeles
Dec. 11, 2010
Temple of Visions’ (www.templeofvisions.com ) beautiful exhibition space in
downtown’s Gallery Row displays world-class contemporary mystical art and is
hosting a late night beneit party for MAPS! The Downtown Independent Theatre
is only a few blocks from Temple of Visions, so attendees of Catalysts will ind it an
easy walk or taxi ride from the day’s earlier events. Flux will feature an incredible
line-up of music and performance late into the night. This event is open to the public
regardless of attendance at the day’s earlier events; tickets will be available through
the MAPS website this fall.
www.maps.org/la2010
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